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The Effectiveness of the Web-based Education Programme Among Cancer Patients

12 de outubro de 2021 atualizado por: Hicran Bektas, Akdeniz University

Development and Evaluation of the Effectiveness of the Web-based Education Programme Among Cancer Patients Undergoing Treatment of Systemic Chemotherapy: A Randomised Controlled Trial

This study aims to develop a web-based education program among cancer patients undergoing treatment of systemic chemotherapy and to evaluate the effect of the program on symptom control, quality of life, self-efficacy, and depression. Evaluating the effect of the web-based education programme among cancer patients will be useful in planning appropriate remote nursing interventions to increase the symptom control and quality of life of patients.

A web-based education program was prepared in line with patient needs, evidence-based guidelines, and expert opinions and tested with 10 cancer patients. A single-blind, randomised controlled study design was applied. Pre-tests were applied to 60 cancer patients undergoing systemic chemotherapy, and the patients (intervention:30, control: 30) were randomized. The intervention group used the web-based education program for three months, and they were allowed to communicate with the researchers 24/7 via the website. The effectiveness of the web-based education program at baseline and after 12 weeks evaluated.

Visão geral do estudo

Descrição detalhada

Cancer is a life-threatening disease with negative physical, psychological, and socioeconomic effects. Patients with cancer receive outpatient chemotherapy and must manage the most important symptoms of chemotherapy at home without the support of a healthcare professional. Patients with cancer and their families need to be supported not only in the hospital but also in the home environment. Patients want to receive information about strategies for coping with symptoms or problems that they encounter frequently after treatment. It has been reported that the rate of use and effectiveness of web-based programs planned by determining the needs of patients with cancer will be higher. Although experimental studies examining the effect of health education and counseling conducted on the web are limited, no web-based education program created by evaluating the needs of patients with cancer has been found. Our study was conducted to determine the needs of patients with cancer for a web-based education program and to design a program to meet the needs.

The primary aim of the study is to develop a web-based education program for patients with cancer receiving systemic treatment and to test the validity of this program. The secondary aim is to evaluate the effect of this web-based education program on symptom control, quality of life, self-efficacy, and depression in patients with cancer undergoing systemic chemotherapy.

In the first stage of the study, the needs of patients for web-based education were determined using a descriptive design, and in the second stage, the effectiveness of the web-based education program was evaluated using a randomized controlled trial design, with the participants being single-blinded. A randomized controlled trial based on the Consolidated Standard of Reporting Trials - CONSORT 2010 - guidelines was performed.

In the first stage of the study, 30 patients with cancer were interviewed to determine their expectations regarding their needs for web-based education. In the second stage of the study, the sample size was calculated on the G*POWER software package based on an 85% power and a 5% confidence interval. The study was conducted with patients with cancer (n=60), including 30 in the intervention and 30 in the control groups. The study consisted of patients who were over the age of 18, received at least two cycles of systemic chemotherapy, had no verbal communication disorder, were literate, had Internet access and use the Internet. Data of both stages of the study were collected between May 7, 2014, and February 17, 2016.

The effect of the web-based education program on patient outcomes was analyzed by dividing the participants into groups through randomization. All patients with cancer who met the sampling criteria were assigned to the intervention and control groups through block randomization (1:1). The researchers used a randomization list created on a computer application (https://www.randomizer.org/). Pretest data of the study were collected from patients who consented to participate in the study by two independent researchers who were not involved in the implementation of the study. For assigning each patient to a group, the other team members were called by the same independent researcher, and the subjects were assigned to the groups according to the randomization list created. Two independent researchers conducted the assignment of the participants on the intervention and control groups and the evaluation of the outcome measurement data. Since the researchers conducted the interventions, they were not be blinded. However, the participants were blinded because they did not know the hypotheses of the study and which group they were in.

In the first phase of the study, a web-based education program was developed. For this purpose, the researchers developed a "Web-Based Education Needs Assessment Form for Patients with Cancer" based on a review of the literature. In line with the needs analysis and literature, the research team created a web-based education program. A group of 10 experts evaluated the content of the program, including three oncology physicians, four nursing faculty members, and three nurses.

After obtaining expert opinions, a pilot study was conducted with 10 different patients with cancer who met the sampling criteria. The intelligibility and usability of the program were tested in the pilot study. Patients with cancer included in the first stage of the study were not included in the second stage.

In the second phase of the study, the web-based education program was introduced to the patients with cancer in the intervention group during face-to-face interviews. They were asked to examine the program for at least two hours a week for three months. During the follow-up period, the patients in the intervention group were called twice a week and reminded to use the education program. The researchers get in contact with the patients online via the website. During the follow-up period, the patients contact the research team by calling or writing messages via the website 24/7. An e-mail account was created by the research team using the email system of the university, and it was shared with the patients. The clinical researchers of the team answered the patients' questions via this e-mail account. Within the scope of the study, a new cell phone number was purchased, and the researchers used on a rotating basis to answer patients' questions as a phone response system. During the follow-up, patients' questions were answered on the phone. The control group received routine patient education and routine hospital follow-ups given by Oncology Education Nurses during the three-month follow-up period. In the third month, after the follow-up stage of the study was completed, the post-tests were administered to the patients in the intervention and control groups who came to the hospital for follow-up or treatment. The outcome measures of the study were determined as the symptoms experienced by patients with cancer, quality of life, self-efficacy, and depression levels.

Tipo de estudo

Intervencional

Inscrição (Real)

53

Estágio

  • Não aplicável

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Between 18-70 years
  • Received at least two cycles of systemic chemotherapy
  • Had no verbal communication disorder
  • Literate
  • Had Internet access
  • Use the Internet

Exclusion Criteria:

  • Having diagnosed with psychiatric disease

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Intervention group
The web-based education program was introduced to the patients with cancer in the intervention group during face-to-face interviews. They were asked to examine the program for at least two hours a week for three months. During the follow-up period, the patients in the intervention group were called twice a week and reminded to use the education program. The researchers get in contact with the patients online via the website. During the follow-up period, the patients contact the research team by calling or writing messages via the website 24/7. An e-mail account was created by the research team using the email system of the university, and it was shared with the patients. The clinical researchers of the team answered the patients' questions via this e-mail account. In the third month, after the follow-up stage of the study was completed, the post-tests were administered to the patients in the intervention group who came to the hospital for follow-up or treatment.
The web-based education program was introduced to the patients with cancer in the intervention group during face-to-face interviews. They were asked to examine the program for at least two hours a week for three months. During the follow-up period, the patients in the intervention group were called twice a week and reminded to use the education program. The researchers get in contact with the patients online via the website. The patients contact the research team by calling or writing messages via the website 24/7. An e-mail account was created by the research team using the email system of the university, and it was shared with the patients. The clinical researchers of the team answered the patients' questions via this e-mail account.
Sem intervenção: Control group
The control group received routine patient education and routine hospital follow-ups given by Oncology Education Nurses during the three-month follow-up period. In the third month, after the follow-up stage of the study was completed, the post-tests were administered to the patients in the control group who came to the hospital for follow-up or treatment.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Rotterdam Symptom Checklist
Prazo: 12 week
The Rotterdam Symptom Checklist is used to evaluate the problems of patients with cancer developing due to the symptoms they experience. The items on the scale are scored between 1 and 4 by using a Likert-type scoring system. The scale consists of 39 items and has 4 sub-dimensions: Physical Symptom Discomfort, Psychological Discomfort, Activity Level, and Quality of Life. The higher the scores obtained from the scale, the greater the distress. Cronbach's alpha value of the scale was determined as 0.88.
12 week
EORTC-QLQ-C30 Quality of Life Scale
Prazo: 12 week
The EORTC-QLQ-C30 Quality of Life Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: General Well-Being, Functional Difficulties, and Symptom Control. The maximum score on the scale is 100, and the minimum is 0. High scores on the functional sub-dimension indicate good/healthy functional status, high scores on the symptom sub-dimension indicate high levels of symptoms and/or problems, and high scores on the global health status/quality of life sub-dimension indicate good quality of life.
12 week
Strategies Used by Patients to Promote Health
Prazo: 12 week
This scale is used to assess the self-confidence of individuals in fulfilling the strategies they use to improve health. It consists of 29 items under 3 sub-dimensions, namely, coping with stress, decision making, and positive behavior development. The scores that can be obtained from the scale range from 29 to 145, and increased scores indicate an increased level of self-efficacy. Cronbach's alpha value of the scale was found as 0.92.
12 week
Beck Depression Scale
Prazo: 12 week
Beck Depression Scale is a self-assessment scale that measures the symptoms of depression observed in physical, emotional, cognitive, and motivational areas. The purpose of the scale is not to diagnose of depression, but to objectively measure the severity of depressive symptoms. Each of the 21 items on the scale includes four statements numbered 0, 1, 2, and 3. Two of the items on the scale are reserved for emotions, eleven items for cognitions, two items for behavior, five items for somatic symptoms, and one item for interpersonal symptoms. The total score that can be obtained from the scale varies between 0 and 63, and the scores are interpreted as follows: 0-9, no depression; 10-15, mild depression, 16-23 moderate depression, and 24-63 severe depression.
12 week

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Diretor de estudo: Hicran Bektas, PhD, RN, Akdeniz University
  • Investigador principal: Hasan S Coskun, Medical Dr, Akdeniz University

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de maio de 2014

Conclusão Primária (Real)

1 de maio de 2015

Conclusão do estudo (Real)

1 de fevereiro de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

29 de setembro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de outubro de 2021

Primeira postagem (Real)

13 de outubro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de outubro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de outubro de 2021

Última verificação

1 de outubro de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2520

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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